Status:
TERMINATED
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive Chronic Hepatitis B in Vietnam
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18+ years
Brief Summary
This prospective, multicenter, observational study will evaluate the sustained response in patients with HBeAg positive chronic hepatitis B who are treated with Pegasys according to standard of care a...
Eligibility Criteria
Inclusion
- Adult patients, \>/= 18 years of age
- HBeAg-positive serologically proven chronic hepatitis B with or without cirrhosis
- Elevated serum ALT \> ULN (upper limit of normal) but \</= 10 x ULN
- Patients with no contra-indications to Pegasys therapy as detailed in the label
- Written informed consent where local regulations allow or require it
Exclusion
- Patients should not receive concomitant therapy with telbivudine
- Co-infection with hepatitis A, hepatitis B or HIV
- Pregnant or breastfeeding women
- Patients with depression/mental diseases
- Neutrophil at baseline \> 90.000/mm3
- Abnormal T4 or TSH
Key Trial Info
Start Date :
September 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01886300
Start Date
September 1 2012
End Date
May 1 2013
Last Update
June 22 2016
Active Locations (3)
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1
Hanoi, Vietnam
2
Ho Chi Minh City, Vietnam, District 5
3
Hochiminh City, Vietnam